FMT for Autism

Phase 1

Waitlist Available

Led By Pat Levitt, Ph.D

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: 5-17 who have been diagnosed with non-syndromic ASD-s

Needs upper GI endoscopy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial is testing if fecal transplants can help treat autism by improving gastrointestinal symptoms and repetitive behaviors.

Who is the study for?

This trial is for children aged 5-17 with Autism Spectrum Disorder (ASD) who have gastrointestinal symptoms. They must be diagnosed using specific autism and GI symptom assessments, need an upper GI endoscopy, and not have any severe sensory or motor problems, genetic syndromic disorders, significant renal/liver dysfunction, immunodeficiency conditions, or severe food allergies.Check my eligibility

What is being tested?

The study tests if fecal microbiota transplantation (FMT)—transferring stool from a healthy donor to the intestines—helps kids with ASD. Participants are randomly chosen to receive either FMT or a saline placebo through an endoscopy into the jejunum.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of FMT may include abdominal discomfort, bloating, diarrhea or constipation. There's also a risk of infection transmission from donor stool.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 5 and 17 years old and have been diagnosed with autism.

Select...

I need an upper GI endoscopy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measures, safety and tolerability

Secondary outcome measures

Measures, symptom improvement

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Arm 2Active Control1 Intervention

Active Comparator: Donor Stool Transplant Arm 2 will get FMT (Fecal Microbial Transplant) with Healthy Donor Stool into the jejunum through upper endoscopy.

Group II: Arm 1Placebo Group1 Intervention

Placebo Comparator placebo into the jejunum through upper endoscopy.

0 / 2Eligibility criteria met